REducing Microvascular Dysfunction in Patients With Angina, Ischaemia and unobstructED coronarY Arteries - a PILOT Study

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test, Other, Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

To demonstrate the feasibility and efficacy of the CS Reducer for the treatment of patients with ischaemia and non-obstructed coronary arteries (INOCA) and coronary microvascular dysfunction (CMD) and through a nested mechanistic substudy investigate the physiological responses in the coronary microcirculation responsible for changes in myocardial perfusion.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age \>18 years

• Ongoing symptomatic angina, CCS Class II-IV, for ≥3 months despite background treatment with at least two anti-anginal drug at the maximal tolerated dose.

• Patients willing to consider no change in anti-anginal drug treatment for the duration of their participation in the trial.

• Unobstructed coronary arteries with ≤50% epicardial stenoses demonstrated on coronary angiography.

• Stress-induced hypoperfusion on CMR (Global MPR ≤ 2.2).

• Willingness to comply with the specified follow-up evaluation and to be contactable during the period of the trial.

• Understands the nature of the trial procedures and provides written informed consent.

Locations
Other Locations
United Kingdom
National Heart and Lung Institute (Brompton Campus), Imperial College London
RECRUITING
London
Contact Information
Primary
Ranil de Silva, FRCP, PhD
r.desilva@imperial.ac.uk
+44 2073518626
Backup
Kevin Cheng, BM BCh, MRCP
kevin.cheng@imperial.ac.uk
+44 2073518626
Time Frame
Start Date: 2023-04-17
Estimated Completion Date: 2026-03-06
Participants
Target number of participants: 54
Treatments
Active_comparator: CS Reducer implantation
Sham_comparator: Sham procedure
Related Therapeutic Areas
Sponsors
Collaborators: St George's University Hospitals NHS Foundation Trust, London North West Healthcare NHS Trust, Imperial College Healthcare NHS Trust, Royal Brompton & Harefield NHS Foundation Trust, East and North Hertfordshire NHS Trust, Liverpool University Hospitals NHS Foundation Trust, Guy's and St Thomas' NHS Foundation Trust, Epsom and St Helier University Hospitals NHS Trust, Bradford Teaching Hospitals NHS Foundation Trust, Kingston Hospital NHS Trust, Oxford University Hospitals NHS Trust
Leads: Imperial College London

This content was sourced from clinicaltrials.gov